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PharmaCompass offers a list of Temozolomide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Temozolomide manufacturer or Temozolomide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Temozolomide manufacturer or Temozolomide supplier.
PharmaCompass also assists you with knowing the Temozolomide API Price utilized in the formulation of products. Temozolomide API Price is not always fixed or binding as the Temozolomide Price is obtained through a variety of data sources. The Temozolomide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Temozolamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Temozolamide, including repackagers and relabelers. The FDA regulates Temozolamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Temozolamide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Temozolamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Temozolamide supplier is an individual or a company that provides Temozolamide active pharmaceutical ingredient (API) or Temozolamide finished formulations upon request. The Temozolamide suppliers may include Temozolamide API manufacturers, exporters, distributors and traders.
click here to find a list of Temozolamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Temozolamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Temozolamide active pharmaceutical ingredient (API) in detail. Different forms of Temozolamide DMFs exist exist since differing nations have different regulations, such as Temozolamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Temozolamide DMF submitted to regulatory agencies in the US is known as a USDMF. Temozolamide USDMF includes data on Temozolamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Temozolamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Temozolamide suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Temozolamide Drug Master File in Japan (Temozolamide JDMF) empowers Temozolamide API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Temozolamide JDMF during the approval evaluation for pharmaceutical products. At the time of Temozolamide JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Temozolamide suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Temozolamide Drug Master File in Korea (Temozolamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Temozolamide. The MFDS reviews the Temozolamide KDMF as part of the drug registration process and uses the information provided in the Temozolamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Temozolamide KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Temozolamide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Temozolamide suppliers with KDMF on PharmaCompass.
A Temozolamide CEP of the European Pharmacopoeia monograph is often referred to as a Temozolamide Certificate of Suitability (COS). The purpose of a Temozolamide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Temozolamide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Temozolamide to their clients by showing that a Temozolamide CEP has been issued for it. The manufacturer submits a Temozolamide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Temozolamide CEP holder for the record. Additionally, the data presented in the Temozolamide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Temozolamide DMF.
A Temozolamide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Temozolamide CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Temozolamide suppliers with CEP (COS) on PharmaCompass.
A Temozolamide written confirmation (Temozolamide WC) is an official document issued by a regulatory agency to a Temozolamide manufacturer, verifying that the manufacturing facility of a Temozolamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Temozolamide APIs or Temozolamide finished pharmaceutical products to another nation, regulatory agencies frequently require a Temozolamide WC (written confirmation) as part of the regulatory process.
click here to find a list of Temozolamide suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Temozolamide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Temozolamide API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Temozolamide as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Temozolamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Temozolamide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Temozolamide suppliers with NDC on PharmaCompass.
Temozolamide Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Temozolamide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Temozolamide GMP manufacturer or Temozolamide GMP API supplier for your needs.
A Temozolamide CoA (Certificate of Analysis) is a formal document that attests to Temozolamide's compliance with Temozolamide specifications and serves as a tool for batch-level quality control.
Temozolamide CoA mostly includes findings from lab analyses of a specific batch. For each Temozolamide CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Temozolamide may be tested according to a variety of international standards, such as European Pharmacopoeia (Temozolamide EP), Temozolamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Temozolamide USP).
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